Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy

This study has suspended participant recruitment.

(We didn't find differences among both groups)

Sponsor:

Coordinación de Investigación en Salud, Mexico

ClinicalTrials.gov Identifier:

NCT01113567

First Posted: April 30, 2010

Last Update Posted: August 10, 2016

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Two groups of patients with minimal hepatic encephalopathy will be studied. The treatment group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive "lactose-free" milk (3.5 g of lactose) two times a day for 21 days. Clinical history, nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency and a quality of life questionnaire will be performed. The patient will be assessed weekly 21 days. An external monitor will control the randomization process in order to allocate the patients into both study group and will not share the assignation codes with anyone until the end of the study.

Mortality due to chronic liver disease is among the first five causes of mortality related to digestive tract and liver diseases in patients on productive age. One of the most frequent complications of chronic liver insufficiency is minimal hepatic encephalopathy (MHE), which affects the quality of life and predisposes to the development of clinical hepatic encephalopathy. There are few evidences on the therapeutic alternatives for minimal hepatic encephalopathy. The administration of non-absorbable disaccharides has been proven to ameliorate MHE. Lactose maldigestion may justify the use of lactose in patients with chronic liver disease as a non-absorbable disaccharide for the treatment of MHE.

The aim of our study is to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of chronic liver disease of whichever etiology

Minimal hepatic encephalopathy

Lactose maldigestion

Exclusion Criteria:

Patients with clinical manifestations of hepatic encephalopathy

Recent use of antibiotics or psychotropic drugs

Recent use of alcohol abuse

Gastrointestinal bleeding

Others neurological disorders that affect the psychometric test

Chronic renal failure

Congestive heart failure

Chronic Obstructive Pulmonary Disease

Severe symptoms of lactose intolerance

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113567